A Study of Patients Receiving High-Dose Rate Brachytherapy

Summary

Background:

* One standard way of giving radiation is to combine external beam treatments with internal brachytherapy treatments, which involve short-range radiation therapy that gives a high dose of radiation directly to a cancer or to the area where cancer cells were removed.
* Brachytherapy is done by placing hollow implant device(s) into the area to be treated and then moving a radiation source into each. The type of device depends on the type of cancer and the site to be treated. These devices can range from hollow applicators and needles to balloon-like equipment.

Objectives:

* To evaluate the quality of the brachytherapy procedure at the National Institutes of Health Radiation Oncology Branch.

Eligibility:

* Patients with cancer who could potentially benefit from high-dose brachytherapy as part of their treatment.

Design:

* In conjunction with their existing treatment, patients will be treated with high-dose brachytherapy as determined appropriate for their particular type of cancer and cancer history.
* Each treatment will take place in the Radiation Oncology Clinic.
* If the patient does not have implant devices, the clinic staff will insert them and check their placement through a computed tomography (CT) scan.
* The calculations to determine the appropriate brachytherapy dose will take a few hours; the brachytherapy treatment itself will take between 10 and 30 minutes.
* The number of brachytherapy treatments will vary according to the individual needs and requirements of each type of cancer and each patient.
* Patients will return to the Radiation Oncology Clinic for follow-up visits at 1, 3, 6, 9, and 12 months after the completion of radiation therapy. Follow-up evaluations will include a medical history and physical examination, assessment of any side effects of radiation therapy, and a repeat of any imaging (i.e., CT, magnetic resonance imaging (MRI), X-ray) that was done at baseline to evaluate the tumor response.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Esophageal Cancer
• Prostate Cancer
• Biliary Cancer

Interventions

RADIATION

High Dose Radiation (HDR) Brachytherapy

Brachytherapy, the placement of a radioactive source close to a tumor, is a well-established part of the treatment of many malignancies, both for palliative and definitive applications. High dose brachytherapy is useful in many malignancies in order to deliver a high dose of radiation therapy to tumor in a conformal fashion with a rapid dose fall-off with the objective of sparing normal surrounding tissue.

DIAGNOSTIC_TEST

MRI

When deemed necessary.

DIAGNOSTIC_TEST

CT

Obtained based on the sites of target, as clinical situation dictates and at each follow-up to determine local control.

DIAGNOSTIC_TEST

PET Scan

When deemed necessary.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Deborah E Citrin, M.D. · National Cancer Institute (NCI)

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-04-14

Primary Completion

2024-05-28

Completion

2025-07-24

FDA Device

Yes

Countries

• United States

Study Locations